Public Release Summary on oestradiol cypionate in the product CIPIOSYN

The APVMA is considering an application for approval of the new active constituent oestradiol cypionate and registration of the product CIPIOSYN as an injectable solution, containing 0.5 mg/mL oestradiol cypionate. The product is used for induction of oestrus and ovulation in cattle as part of a reproductive management programme.

The APVMA is able to consider comments relating to the legislative grounds, including:

• chemistry and manufacture
• occupational health and safety
• public health
• environmental safety
• residues in food
• trade
• efficacy and target animal safety

We invite submissions from 8 September 2020 to 6 October 2020 on whether approval of the active constituent and registration of the product should be granted.

Download the Public Release Summary on the evaluation of CIPIOSYN.

For more information see page 29, APVMA Gazette No.18 8 September 2020.

Please note: Submissions will be published on the APVMA’s website, unless you have asked for the submission to remain confidential (see public submission coversheet).

Please lodge your submission with a public submission coversheet, which provides options for how your submission will be published.

Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.

Please send your written submission and coversheet by email or post to:

Email: enquiries@apvma.gov.au

Post:
Case Management and Administration Unit
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001

Submissions received

The APVMA sought comments from interested stakeholders on oestradiol cypionate in the product CIPIOSYN, in a consultation that closed on 6 October 2020.

No submissions were received. We have finalised registration of the product.